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Repacker with one line - looking into voluntary auditing

Started by , Mar 13 2015 04:13 PM
9 Replies

My company runs a small operation. We purchase our formulated candies in bulk and pack them in house so essentially, only a repack operation. 
 
We are considering a GMP audit and although I am Director of Operations, quality also falls under me.  We considered a Siliker GMP audit and as I dug deeper, it requires that the HACCP Manager is a certified person.
 
Now we want to do things RIGHT but are also at square one. Would anyone have recommendations on a good first step GMP audit that will keep us from having to certify a HACCP manager? I know HACCP from working with it and researching and I have also built our program in house. It seems I'd end up having to pay $750 for a class that's going to just be a review of things I already know. 
 
I appreciate anyone's recommendations!

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Dietary Supplement Repacker requirements such as the Master Manufacturing Record Is a repacker a manufacturer? And what is the difference between a processor/re-processor? Mock recall for a repacker of dried bulk ingredients Repacker and Traceability
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Certified by whom? And to what end, if you are paying for an audit, i don't understand why there would be a requirement from an auditing third party...... I would suggest that Siliker isn't interested in your best interests, but is trying to sell you another product....but that could just be jaded ole me. There are plenty of on-line course options to "certify you" that cost significantly less than 750.

$750 isn't through Siliker, it's thought NSF which is where I did my PRP training.

AIB also requires "Documented HACCP training" (AIB Consolidated Standards for Inspection - Prerequisite and Food Safety Programs 5.25.1.3) - it is listed as a critical requirement.

 

I am in a similar situation -- I learned HACCP on my own, but it wasn't sufficient to meet the AIB requirements for our annual 3rd party GMP inspection. So, I did an online webinar with them, which was OK.  Best part of it though: You get to submit your own plan as your final exam, which is a great way to have another set of eyes on your plan - especially if you are part of a small company without anyone else who knows more than you.  And there's an opportunity for dialogue with the instructor.

I was looking at doing a course through NSF which is generally a one day webinar, sometimes two days. 

 

Where did you get HACCP certified that you were able to submit your plan for review? That is a great bonus!

It was the AIB Course.  You can either opt to write a HACCP plan for a scenario they give you, or for a few extra $$$ you can submit your own as your final exam.  

Here's a link:

http://www.aibonline...logNbr=11-3140A

Do you know if this certifies you for any HACCP or only those that are AIB? I ask because we are not AIB 

Auditors like to see the HACCP Coordinator certified through an accredited source usually the seal on the certificate would read IHA for the International HACCP Alliance.

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Spend the money, you then have a record of being certified. If you expand your operation in any way or move on to another position that requires HACCP cert you are set. Also, keep in mind that FSMA will require a new type of HACCP labeled HARPC, and there will need to be a person trained and certified.

FYI we went with a GMP audit through ASI which worked well for us - we got a large hit on our pest control which was a surprise as we assumed what we had was OK per the company's recommendation - not so.

 

Anyways, next question wondering what's next with HARPC - I know there are complex codes to follow, but I am looking for a summary as to what and when I am required to comply with. 


Similar Discussion Topics
Dietary Supplement Repacker requirements such as the Master Manufacturing Record Is a repacker a manufacturer? And what is the difference between a processor/re-processor? Mock recall for a repacker of dried bulk ingredients Repacker and Traceability